Method and apparatus for passing suture through tissue

ABSTRACT

A suture passer comprising:
         a hollow tube, the hollow tube comprising a distal end, a proximal end, and a lumen extending from the distal end to the proximal end; and   a clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, one of the first and second arms extending distally of the other of the first and second arms and including a clamping surface;
           wherein at least one of the first arm and the second arm comprises a friction-enhancing surface for facilitating manipulation of a suture via engagement of the suture with the friction-enhancing surface.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application is a continuation of prior U.S. patentapplication Ser. No. 13/791,395, filed Mar. 8, 2013 by Pivot Medical,Inc. for METHOD AND APPARATUS FOR PASSING SUTURE THROUGH TISSUE, whichpatent application in turn:

(i) is a continuation-in-part of prior U.S. patent application Ser. No.13/230,652 filed Sep. 12, 2011 by James Flom et al. for METHOD ANDAPPARATUS FOR PASSING SUTURE THROUGH TISSUE, which patent application inturn claims benefit of: (a) prior U.S. Provisional Patent ApplicationSer. No. 61/384,423, filed Sep. 20, 2010 by Chris Pamichev et al. forMETHOD AND APPARATUS FOR PASSING SUTURE THROUGH TISSUE DURING ANARTHROSCOPIC PROCEDURE, INCLUDING THE PROVISION AND USE OF A NOVEL SPEARSUTURE PASSER; (b) prior U.S. Provisional Patent Application Ser. No.61/473,219, filed Apr. 8, 2011 by James Flom et al. for METHOD ANDAPPARATUS FOR PASSING SUTURE THROUGH TISSUE; (c) prior U.S. ProvisionalPatent Application Ser. No. 61/495,441, filed Jun. 10, 2011 by JamesFlom et al. for METHOD AND APPARATUS FOR PASSING SUTURE THROUGH TISSUE;and (d) prior U.S. Provisional Patent Application Ser. No. 61/381,787,filed Sep. 10, 2010 by Thomas Weisel for PINCH PASSER; and

(ii) prior U.S. Provisional Patent Application Ser. No. 61/701,920,filed Sep. 17, 2012 by Daren Stewart et al. for METHOD AND APPARATUS FORPASSING SUTURE THROUGH TISSUE.

The seven (7) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to surgical apparatus and procedures in general,and more particularly to surgical apparatus and procedures for passingsuture through tissue.

BACKGROUND OF THE INVENTION

In many situations suture must be passed through tissue. In opensurgical procedures, the suture is typically attached to a needle andthe needle is then used to draw the suture through the tissue. However,in closed surgical procedures (e.g., so-called “keyhole” surgeries,where an interior surgical site is accessed through a narrow cannula),it can be difficult to advance a needle (and particularly a curvedneedle) to the interior surgical site, and it can be even more difficultto maneuver the needle about the interior surgical site. Furthermore, inclosed surgical procedures, it is frequently necessary to advance thesuture through tissue, and then to retrieve the suture on the far sideof the tissue, so that the suture can thereafter be drawn back throughthe tissue, e.g., at a second point of penetration. Conventional needlesare typically inadequate for these situations.

On account of the foregoing, in closed surgical procedures, it is commonto use a suture passer to pass suture through tissue, e.g., at a remotesurgical site. Such suture passers are dedicated suture passinginstruments generally comprising a shaft, a tissue-penetrating andsuture-carrying working tip set at the distal end of the shaft, and ahandle set at the proximal end of the shaft. However, such suturepassers all tend to suffer from one or more deficiencies, including butnot limited to: (i) size; (ii) a need to place the suture adjacent to anedge of the tissue; (iii) difficulty in picking up suture on the farside of the tissue; (iv) complexity of operation; (v) cost ofmanufacture, etc.

Thus there is a need for a new and improved method and apparatus forpassing suture through tissue which does not suffer from one or more ofthe disadvantages associated with the prior art.

SUMMARY OF THE INVENTION

The present invention provides a new and improved method and apparatusfor passing suture through tissue.

In one form of the present invention, there is provided a suture passercomprising:

a hollow tube, the hollow tube comprising a distal end, a proximal end,a lumen extending from the distal end to the proximal end, and a windowformed in the sidewall of the hollow tube, the window communicating withthe lumen; and

a clamping rod slidably received in the lumen of the hollow tube, theclamping rod comprising a distal end and a proximal end, the distal endbeing bifurcated into a first arm and a second arm, one of the first andsecond arms extending distally of the other of the first and second armsand including a clamping surface, and at least one of the first andsecond arms being outwardly biased such that when the clamping rod ismoved distally so that the distal end of the at least one outwardlybiased arm is adjacent to the window, the distal end of the at least oneoutwardly biased arm extends outwardly through the window.

In another form of the present invention, there is provided a method forpassing suture through an object, the method comprising:

providing a suture passer comprising:

-   -   a hollow tube, the hollow tube comprising a distal end, a        proximal end, a lumen extending from the distal end to the        proximal end, and a window formed in the sidewall of the hollow        tube, the window communicating with the lumen; and    -   a clamping rod slidably received in the lumen of the hollow        tube, the clamping rod comprising a distal end and a proximal        end, the distal end being bifurcated into a first arm and a        second arm, one of the first and second arms extending distally        of the other of the first and second arms and including a        clamping surface, and at least one of the first and second arms        being outwardly biased such that when the clamping rod is moved        distally so that the distal end of the at least one outwardly        biased arm is adjacent to the window, the distal end of the at        least one outwardly biased arm extends outwardly through the        window;

positioning the clamping rod so that the at least one outwardly biasedarm extends out of the window;

positioning at least one of the suture passer and the suture so that thesuture is disposed in the window;

moving the clamping rod proximally so that the clamping surface clampsthe suture to the hollow tube; and

moving the suture passer so that the suture is passed through theobject.

In another form of the present invention, there is provided a suturepasser comprising:

a hollow tube, the hollow tube comprising a pointed distal end, aproximal end and a lumen extending from the distal end to the proximalend; and

a clamping rod slidably received in the lumen of the hollow tube, theclamping rod comprising a distal end and a proximal end, the distal endbeing bifurcated into a first arm and a second arm, the first armextending distally of the second arm and including a clamping surface,and the second arm being outwardly biased such that when the clampingrod is moved distally so that the distal end of the second arm extendsout of the distal end of the hollow tube, the distal end of the secondarm extends laterally of the hollow tube.

In another form of the present invention, there is provided a method forpassing suture through an object, the method comprising:

providing a suture passer comprising:

-   -   a hollow tube, the hollow tube comprising a pointed distal end,        a proximal end and a lumen extending from the distal end to the        proximal end; and    -   a clamping rod slidably received in the lumen of the hollow        tube, the clamping rod comprising a distal end and a proximal        end, the distal end being bifurcated into a first arm and a        second arm, the first arm extending distally of the second arm        and including a clamping surface, and the second arm being        outwardly biased such that when the clamping rod is moved        distally so that the distal end of the second arm extends out of        the distal end of the hollow tube, the distal end of the second        arm extends laterally of the hollow tube;

positioning the clamping rod so that the second arm extends out of thedistal end of the hollow tube;

positioning at least one of the suture passer and the suture so that thesuture is disposed between the clamping surface and the distal end ofthe hollow tube;

moving the clamping rod proximally so that the clamping surface clampsthe suture to the hollow tube; and

moving the suture passer so that the suture is passed through theobject.

In another form of the present invention, there is provided a suturepasser comprising:

a shaft comprising a distal end, a proximal end, a lumen extending fromthe proximal end toward the distal end, and a window formed in thesidewall of the shaft, the window communicating with the lumen; and

a suture spear movable within the lumen of the shaft, the suture spearcomprising a distal end and a proximal end, the distal end being pointedto pierce a suture located in the window.

In another form of the present invention, there is provided a method forpassing suture through an object, the method comprising:

providing a suture passer comprising:

-   -   a shaft comprising a distal end, a proximal end, a lumen        extending from the proximal end toward the distal end, and a        window formed in the sidewall of the shaft, the window        communicating with the lumen; and    -   a suture spear movable within the lumen of the shaft, the suture        spear comprising a distal end and a proximal end, the distal end        being pointed to pierce a suture located in the window.

positioning the suture spear so that it is disposed proximal to thewindow;

positioning at least one of the suture passer and the suture so that thesuture is disposed in the window;

moving the suture spear distally so that the suture spear extends intothe suture disposed in the window; and

moving the suture passer so that the suture is passed through theobject.

In another form of the present invention, there is provided a suturepasser comprising:

a hollow tube, the hollow tube comprising a distal end, a proximal end,a lumen extending from the distal end to the proximal end, and a windowformed in the sidewall of the hollow tube, the window communicating withthe lumen; and

a clamping rod slidably received in the lumen of the hollow tube, theclamping rod comprising a distal end and a proximal end, the distal endincluding a clamping surface, and the distal end being outwardly biasedsuch that when the clamping rod is moved distally so that the distal endof the clamping rod is adjacent to the window, the distal end of theclamping rod extends outwardly through the window.

In another form of the present invention, there is provided a method forpassing suture through an object, the method comprising:

providing a suture passer comprising:

-   -   a hollow tube, the hollow tube comprising a distal end, a        proximal end, a lumen extending from the distal end to the        proximal end, and a window formed in the sidewall of the hollow        tube, the window communicating with the lumen; and    -   a clamping rod slidably received in the lumen of the hollow        tube, the clamping rod comprising a distal end and a proximal        end, the distal end including a clamping surface, and the distal        end being outwardly biased such that when the clamping rod is        moved distally so that the distal end of the clamping rod is        adjacent to the window, the distal end of the clamping rod        extends outwardly through the window;

positioning the clamping rod so that the distal end of the clamping rodextends out of the window;

positioning at least one of the suture passer and the suture so that thesuture is disposed in the window;

moving the clamping rod proximally so that the clamping surface clampsthe suture to the hollow tube; and

moving the suture passer so that the suture is passed through theobject.

In another form of the present invention, there is provided a suturepasser comprising:

a hollow tube, the hollow tube comprising a distal end, a proximal end,and a lumen extending from the distal end to the proximal end; and

a clamping rod slidably received in the lumen of the hollow tube, theclamping rod comprising a distal end and a proximal end, the distal endbeing bifurcated into a first arm and a second arm, one of the first andsecond arms extending distally of the other of the first and second armsand including a clamping surface;

wherein at least one of the first arm and the second arm comprises afriction-enhancing surface for facilitating manipulation of a suture viaengagement of the suture with the friction-enhancing surface.

In another form of the present invention, there is provided a method forpassing suture through an object, the method comprising:

providing a suture passer comprising:

-   -   a hollow tube, the hollow tube comprising a distal end, a        proximal end, and a lumen extending from the distal end to the        proximal end; and    -   a clamping rod slidably received in the lumen of the hollow        tube, the clamping rod comprising a distal end and a proximal        end, the distal end being bifurcated into a first arm and a        second arm, one of the first and second arms extending distally        of the other of the first and second arms and including a        clamping surface;    -   wherein at least one of the first arm and the second arm        comprises a friction-enhancing surface for facilitating        manipulation of a suture via engagement of the suture with the        friction-enhancing surface;

positioning the clamping rod so that at least one of the first arm andthe second arm extends out of the hollow tube;

manipulating a suture via engagement of the suture with thefriction-enhancing surface on the at least one of the first arm and thesecond arm;

positioning at least one of the suture passer and the suture so that thesuture is disposed between the first arm and the second arm;

moving the clamping rod proximally so that the clamping surface clampsthe suture to the hollow tube; and

moving the suture passer so that the suture is passed through theobject.

In another form of the present invention, there is provided a suturepasser comprising:

a hollow tube, the hollow tube comprising a pointed distal end, aproximal end and a lumen extending from the distal end to the proximalend; and

a clamping rod slidably received in the lumen of the hollow tube, theclamping rod comprising a distal end and a proximal end, the distal endbeing bifurcated into a first arm and a second arm, the first armextending distally of the second arm and including a clamping surface,and the second arm being outwardly biased such that when the clampingrod is moved distally, the distal end of the second arm extendslaterally of the hollow tube, and wherein the second arm is configuredto releasably hold a suture to the distal end of the second arm.

In another form of the present invention, there is provided a method forpassing suture through an object, the method comprising:

providing a suture passer comprising:

-   -   a hollow tube, the hollow tube comprising a pointed distal end,        a proximal end and a lumen extending from the distal end to the        proximal end; and    -   a clamping rod slidably received in the lumen of the hollow        tube, the clamping rod comprising a distal end and a proximal        end, the distal end being bifurcated into a first arm and a        second arm, the first arm extending distally of the second arm        and including a clamping surface, and the second arm being        outwardly biased such that when the clamping rod is moved        distally so that the distal end of the second arm extends out of        the distal end of the hollow tube, the distal end of the second        arm extends laterally of the hollow tube, and wherein the second        arm is configured to releasably hold a suture to the distal end        thereof;

positioning the clamping rod so that the second arm extends out of thedistal end of the hollow tube;

positioning at least one of the suture passer and the suture so that thesuture is disposed between the clamping surface and the distal end ofthe hollow tube;

moving the clamping rod proximally so that the clamping surface clampsthe suture to the hollow tube;

moving the suture passer so that the suture is passed through theobject; and

moving the clamping rod distally so that the distal end of the secondarm moves the suture away from the hollow tube.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIGS. 1-11 are schematic views showing a novel suture passer formed inaccordance with the present invention;

FIGS. 12-25 are schematic views showing an exemplary manner of passingsuture using the novel suture passer of FIGS. 1-11;

FIGS. 26-29 are schematic views showing various configurations for theclamping surface of the first arm of the clamping rod of the suturepasser of FIGS. 1-11;

FIGS. 29A and 29B are schematic views showing a modified form of thenovel suture passer of FIGS. 1-11, wherein an arm of the suture passerincludes a plurality of suture-engaging projections on its distal side;

FIGS. 29C and 29D are schematic views showing a modified form of thenovel suture passer of FIGS. 1-11, wherein an arm of the suture passerincludes a plurality of suture-engaging projections on its proximalside;

FIGS. 30 and 31 are schematic views showing another configuration forthe suture passer of the present invention, wherein the clamping rod andhollow tube are configured so as to allow suture to slide between theclamping rod and the hollow tube;

FIGS. 32 and 33 are schematic views showing another configuration forthe suture passer of the present invention, wherein the clamping rod isconfigured to pierce the suture when the clamping rod is movedproximally;

FIGS. 34 and 35 are schematic views illustrating how the lengths of thefirst and second arms of the bifurcated distal end of the clamping rodcan vary from the construction shown in FIGS. 1-11;

FIGS. 35A-35C are schematic views showing another novel form of suturepasser formed in accordance with the present invention;

FIGS. 35D-35F are schematic views showing the novel suture passer ofFIGS. 35A-35C securing a suture to the distal end of the suture passer;

FIGS. 35G-35I are schematic views showing another novel form of suturepasser formed in accordance with the present invention;

FIGS. 35J-35L are schematic views showing the novel suture passer ofFIGS. 35G-35I securing a suture to the distal end of the suture passer;

FIGS. 35M-35O are schematic views showing another novel form of suturepasser formed in accordance with the present invention;

FIGS. 35P-35R are schematic views showing the novel suture passer ofFIGS. 35M-35O securing a suture to the distal end of the suture passer;

FIGS. 36-40 are schematic views showing another novel form of suturepasser formed in accordance with the present invention;

FIGS. 40A and 40B are schematic views showing a modified form of thenovel suture passer of FIGS. 36-40, wherein an arm of the suture passerincludes a plurality of suture-engaging projections on its distal side;

FIGS. 41-47 are schematic views showing still another novel form ofsuture passer formed in accordance with the present invention;

FIGS. 48-60 are schematic views showing yet another novel form of suturepasser formed in accordance with the present invention;

FIGS. 61-64 are schematic views showing an exemplary manner of passingsuture using the novel suture passer of FIGS. 48-60; and

FIGS. 65-67 show variations of the novel suture passer shown in FIGS.48-60;

FIGS. 68-81 are schematic views showing another novel form of suturepasser formed in accordance with the present invention;

FIGS. 82-84 are schematic views showing another novel form of suturepasser formed in accordance with the present invention; and

FIGS. 85 and 86 are schematic views showing still another novel form ofsuture passer formed in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a new and improved method and apparatusfor passing suture through tissue.

The Novel Suture Passer

Looking first at FIGS. 1-11, there is shown a novel suture passer 5formed in accordance with the present invention. Suture passer 5generally comprises a hollow tube 10 and a clamping rod 15 slidablydisposed within the lumen of hollow tube 10, as will hereinafter bediscussed in further detail.

More particularly, hollow tube 10 comprises a distal end 20 preferablyterminating in a sharp point 22, and a proximal end 25 preferablyterminating in a handle 23, with a lumen 30 extending therebetween. Itwill be appreciated that the pointed hollow tube 10 essentiallycomprises a hollow needle adapted to pierce tissue.

Hollow tube 10 further comprises a window 35 which extends radially intothe hollow tube and communicates with lumen 30. Window 35 is sized so asto selectively receive a suture S therein, as will hereinafter bediscussed in further detail. Window 35 preferably comprises an inclineddistal surface 40 and an inclined proximal surface 45. Preferably,distal surface 40 and proximal surface 45 are inclined in the samedirection, and preferably both surfaces are inclined distally (e.g., inthe manner shown in FIGS. 1-11). The forward incline of inclined distalsurface 40 allows suture to more easily pass into and out of window 35.The forward incline of inclined proximal surface 45 provides an undercutwhich helps to trap the suture S between the clamping surface 47 ofclamping rod 15 and the inclined proximal surface 45 of window 35, aswill hereinafter be discussed in further detail.

Hollow tube 10 is preferably formed out of a substantially rigidmaterial (e.g., stainless steel) so as to maintain rigidity when passingthrough tissue, particularly relatively tough fibrous tissue (e.g., thelabrum of the hip).

In one preferred form of the present invention, the distal end 20 ofhollow tube 10 is curved, however, it should be appreciated that hollowtube 10 can be formed in other configurations well known in the art(e.g., straight, etc.).

Clamping rod 15 comprises a distal end 50 (FIG. 9) and a proximal end 55(FIG. 9). Distal end 50 of clamping rod 15 is bifurcated so as to form afirst arm 60 and a second arm 65.

First arm 60 comprises the aforementioned clamping surface 47, withclamping surface 47 extending radially from the longitudinal axis ofclamping rod 15. Clamping surface 47 may take the form of a hook, asshown in FIGS. 1-11. This hook helps trap the suture S between clampingsurface 47 of clamping rod 15 and inclined proximal surface 45 of window35, in the manner shown in FIGS. 10 and 11.

Second arm 65 extends parallel to first arm 60 when clamping rod 15 isdisposed within lumen 30 of hollow tube 10, with second arm 65terminating proximally of first arm 60, shy of clamping surface 47.

Second arm 65 is outwardly biased so that when second arm 65 advancespast window 35, second arm 65 passes radially outwardly through window35 so as to project at an angle of approximately 10-120 degrees relativeto the longitudinal axis of first arm 60 (FIG. 6), and more preferablyat an angle of approximately 30-90 degrees to the longitudinal axis offirst arm 60, whereby to create a funnel region 75 between hollow tube10 and second arm 65 when second arm 65 extends out window 35. To thisend, second arm 65 is preferably formed out of a material consistentwith this spring bias (e.g., a superelastic material such as Nitinol,etc.). In one preferred form of the invention, the entire clamping rod15 is formed out of a superelastic material such as Nitinol.

The proximal end 55 of clamping rod 15 extends through lumen 30 ofhollow tube 10 and is connected to an actuator 72 (FIG. 1) which ismovably mounted to handle 23, such that movement of actuator 72 relativeto handle 23 will cause movement of clamping rod 15 relative to hollowtube 10.

It will be appreciated that, on account of the foregoing construction, apiece of suture S may be clamped to the distal end of suture passer 5 by(i) moving clamping rod 15 to the position shown in FIGS. 5 and 6 (e.g.,by moving actuator 72 distally relative to handle 23) so that clampingsurface 47 of first arm 60 is distal to window 35, and so that secondarm 65 extends out of window 35; (ii) positioning the suture S in window35 (FIGS. 7-9); and (iii) moving clamping rod 15 proximally (e.g., bymoving actuator 72 proximally relative to handle 23) so as to causeclamping surface 47 of first arm 60 to clamp suture S against proximalsurface 45 of window 35, as shown in FIGS. 10 and 11. In this respect itwill be appreciated that the creation of the funnel region 75(established between hollow tube 10 and the extended second arm 65) atthe mouth of window 35 facilitates guidance of suture S into window 35,as shown in FIGS. 7-9.

It will also be appreciated that, on account of the foregoingconstruction, a clamped piece of suture may thereafter be released fromsuture passer 5 by (a) moving clamping rod 15 distally (FIGS. 8 and 9)so as to space clamping surface 47 of first arm 60 away from proximalsurface 45 of window 35; and (b) causing suture S to be withdrawn fromwindow 35 (FIG. 7), either by moving suture S relative to suture passer5 or by moving suture passer 5 relative to suture S or by moving bothsuture S and suture passer 5 relative to one another.

It should be appreciated that, in one preferred form of the invention,when clamping rod 15 is moved proximally, both first arm 60 and secondarm 65 are disposed within lumen 30 of hollow tube 10, so that thedistal end of suture passer 5 presents a smooth outer surface, wherebyto facilitate passage of the distal end of suture passer 5 throughtissue.

Using the Novel Suture Passer to Pass Suture from the Near Side ofTissue to the Far Side of Tissue

In one preferred form of the present invention, and looking now at FIGS.12-18, the novel suture passer 5 can be used to pass suture S from thenear side of tissue T to the far side of tissue T (i.e., in an“antegrade” manner).

More particularly, the preliminary loading of suture S into suturepasser 5 may be performed away from the surgical site (e.g., outside ofthe patient) or it may be performed adjacent to the near side of thetissue T which is to be sutured (e.g., inside of the patient). As seenin FIG. 12, clamping rod 15 is advanced to its most distal position sothat second arm 65 advances out of window 35, whereby to project out ofthe axis of hollow tube 10 and create the aforementioned funnel region75. Suture S is then guided into window 35 using this funnel effect, asseen in FIG. 13, either by moving suture S relative to suture passer 5or by moving suture passer 5 relative to suture S or by moving bothsuture S and suture passer 5 relative to one another. Clamping rod 15 isthen retracted proximally so that clamping surface 47 clamps suture Sbetween clamping surface 47 of first arm 60 and proximal surface 45 ofwindow 35. See FIG. 14.

Suture passer 5 is then advanced distally so that window 35 passesthrough tissue T, whereby to carry suture S through the tissue (FIG.15). With suture S extending through tissue T, and looking now at FIG.16, clamping rod 15 is advanced distally so that clamping surface 47 isdisposed distal to window 35, thereby releasing suture S from suturepasser 5. Suture passer 5 and/or suture S are then manipulated so thatsuture S is clear of window 35 (FIG. 17). Clamping rod 15 is then movedproximally so as to retract first arm 60 and second arm 65 back intohollow tube 10. Suture passer 5 may then be withdrawn back throughtissue T, leaving suture S extending through tissue T, as shown in FIG.18.

Using the Novel Suture Passer to Draw Suture from the Far Side of Tissueto the Near Side of Tissue

In another preferred form of the present invention, and looking now atFIGS. 19-25, the novel suture passer 5 can be used to draw suture S fromthe far side of tissue T to the near side of tissue T (i.e., in a“retrograde” manner).

More particularly, in this form of the invention, the suture S is loadedinto suture passer 5 on the far side of the tissue T. This is done byfirst passing suture passer 5 through tissue T so that window 35 resideson the far side of the tissue, and then moving clamping rod 15 distallyso that second arm 65 extends out of window 35, substantiallyperpendicularly to hollow tube 10, whereby to create the aforementionedfunnel region 75 (FIGS. 19 and 20). This funnel effect is then used toguide free suture (disposed on the far side of tissue T) into window 35(see FIG. 21), either by moving suture S relative to suture passer 5 orby moving suture passer 5 relative to suture S or by moving both sutureS and suture passer 5 relative to one another. If desired, the suture Smay be tensioned so as to help draw it into the window 35.

Next, clamping rod 15 is retracted proximally so as to releasably securesuture S between clamping surface 47 and proximal surface 45 of window35 (FIG. 22). Hollow tube 10 is then retracted proximally through tissueT, carrying suture S therethrough (FIG. 23). If desired, suture S canthen be released from suture passer 5 by moving clamping rod 15 distally(FIGS. 24 and 25).

Significantly, by alternating the aforementioned antegrade suturepassing procedure (FIGS. 12-18) with the aforementioned retrogradesuture passing procedure (FIGS. 19-25), with the needle “plunges” beinglaterally spaced from one another in the tissue (FIG. 19), a mattressstitch may be placed in the tissue (FIG. 25).

If desired, the novel suture passer 5 may also be used to pass suture Saround a side edge of the tissue T, rather than passing the suture Sthrough the tissue. By way of example but not limitation, if the hollowtube 10 is passed around the side edge of the tissue (rather thanthrough it), the suture passer could then be used to retrieve the sutureon the far side of the tissue and draw it back around the side edge ofthe tissue so that the suture is brought to the near side of the tissue.

As described above, the novel suture passer 5 has the ability to bothpass (advance) and retrieve (draw) the suture S through and/or aroundthe tissue in a continuous series of steps. This allows the surgeon tocomplete the desired suture passing without having to remove the suturepasser 5 from the portal through which the suture passer 5 is beingused. Significantly, this passing/retrieving process can be accomplishedwith a single instrument, rather than requiring one instrument forpassing and a separate instrument for retrieving. This offerssignificant advantages in convenience and in reducing surgery time.

Alternative Embodiments

As noted above, clamping surface 47 of clamping rod 15 may take the formof a hook, as shown in FIGS. 1-11. This hook may have various degrees ofdepth and return, as seen in FIGS. 26-28. Alternatively, clampingsurface 47 may be substantially flat, as shown in FIG. 29.

In addition, and looking now at FIGS. 29A and 29B, if desired, secondarm 65 of suture passer 5 may include a plurality of suture-engagingprojections 76 on its distal side. Suture-engaging projections 76 allowthe user to more aggressively engage (e.g., in a contact or frictionalsense) suture S with second arm 65, whereby to facilitate manipulationof suture S via engagement with second arm 65. Thus, for example, withthe construction shown in FIGS. 29A and 29B, if the user needs to movethe suture S about a surgical site, the user can “grip” the suture Swith the suture-engaging projections 76 of second arm 65 and “drag” thesuture S into a desired position. In another example, thesuture-engaging projections 76 of second arm 65 can assist in draggingsuture S into window 35. More particularly, as the clamping rod 15 ismoved proximally in hollow tube 10, the second arm 65 retracts into thelumen of the hollow tube 10. As it does so, if the suture S is incontact with the suture-engaging projections 76 of second arm 65, sutureS will be drawn into window 35. Once in window 35, the suture S is thenclamped between clamping surface 47 of clamping rod 15 and inclinedproximal surface 45 of window 35 as described above.

Alternatively, and looking now at FIGS. 29C and 29D, second arm 65 ofsuture passer 5 may include a plurality of suture-engaging projections76 on its proximal side. Again, suture-engaging projections 76 allow theuser to more aggressively engage (e.g., in a contact or frictionalsense) suture S with second arm 65, whereby to facilitate manipulationof suture S via engagement with second arm 65.

If desired, suture-engaging projections 76 may also be provided on boththe distal and proximal sides of second arm 65, and/or on one or both ofthe lateral sides of second arm 65.

It will be appreciated that suture-engaging projections 76 essentiallyconstitute a friction-enhancing surface on second arm 65 so as to allowsecond arm 65 to engage and “drag” suture S about a surgical site. Tothis end, it will also be appreciated that the friction-enhancingsurface(s) on second arm 65 may be formed with a variety of geometries,e.g., barbs, fingers, ribs, threads or other surface texturing whichincreases the frictional aspects of second arm 65 at a desired locationor locations.

Furthermore, if desired, the suture passer may be constructed so thatthe suture S is slidably captured—but not clamped—between clampingsurface 47 of clamping rod 15 and inclined proximal surface 45 of window35. In this form of the invention, suture S is slidably captured betweenthe two surfaces (i.e., clamping surface 47 and proximal surface 45), inthe manner shown in FIGS. 30 and 31. In this form of the invention,clamping rod 15 may be limited in its proximal travel (e.g., by means ofinteraction between actuator 72 and handle 23) in order to provide a gapsufficient to slidingly capture, but not bind, suture S. This gap may beequal to, or larger than, the diameter of suture S.

Alternatively, if desired, the clamping rod can be configured to piercethe suture when the clamping rod is moved proximally, as shown in FIGS.32 and 33. This spearing of the suture can enhance clamping of thesuture S to the suture passer 5. By way of example but not limitation,first arm 60 of clamping rod 15 may include a pointed return 77, withpointed return 77 being configured and located such that it will spearsuture S when clamping rod 15 is moved proximally.

It should be appreciated that the lengths of the first and second arms60, 65 of clamping rod 15 can vary from the construction shown in FIGS.1-11. By way of example but not limitation, in one preferred form of theinvention, the distance between the distal tip of second arm 65 andclamping surface 47 is approximately the length of window 35, as shownin FIG. 34. In another preferred form of the invention, only a nominalgap is provided between the distal tip of second arm 65 and clampingsurface 47 (FIG. 35). This construction can provide for improvedcapturing of suture S to suture passer 5.

In another form of the present invention, suction may be applied tolumen 30 of hollow tube 10 proximal to window 35. This suction will drawfluid into window 35, and the fluid entering window 35 will assistsuture S in seating itself into window 35 as the suture S approacheswindow 35.

In another form of the present invention, fluid is delivered down lumen30 of hollow tube 10 so as to assist ejection of suture S from window 35once the clamping rod 15 has released suture S.

In yet another form of the present invention, hollow tube 10 comprises asecond window 35 opposite first window 35, and the distal end ofclamping rod 15 is trifurcated so as to form a first arm 60 carrying apair of clamping surfaces 47 and a pair of second arms 65, with each ofthe second arms 65 being outboard of first arm 60 and being biased out awindow 35. Thus, with this construction, suture can be clamped on eitherside of hollow tube 10.

In another form of the present invention, the suture passer may furthercomprise a push rod to assist in ejecting suture S from window 35. Thepush rod may be a component separate from clamping rod 15 (but slidablymovable relative thereto), or it may be integrated with clamping rod 15(e.g., slidably movable thereon).

Looking next at FIGS. 35A-35C, it is also possible to form novel suturepasser 5 so that (i) first arm 60 is shorter than second arm 65, and(ii) clamping surface 47 is formed on the outwardly biased second arm 65(rather than on first arm 60). In this form of the invention, funnelregion 75 is formed between the distal end of shaft 10 and first arm 60.FIGS. 35D-35F show the novel suture passer of FIGS. 35A-35C securing asuture S to the distal end of the suture passer.

Furthermore, if desired, where clamping surface 47 is formed on theoutwardly biased second arm 65 (e.g., in the manner shown in FIGS.35A-35C and FIGS. 35D-35F), first arm 60 may be omitted entirely, inwhich case the distal end of clamping rod 15 preferably comprises onlyoutwardly biased second arm 65.

In another form of the present invention, and looking now at FIGS.35G-35I, novel suture passer 5 may be constructed so that first arm 60(carrying clamping surface 47) is outwardly biased, so that first arm 60(and clamping surface 47) extends out window 35 when clamping rod 15 ismoved distally. In this form of the invention, the funnel region 75 isformed between the distal end of shaft 10 and first arm 60. FIGS.35J-35L show the novel suture passer of FIGS. 35G-35I securing a sutureS to the distal end of the suture passer.

Furthermore, if desired, where first arm 60 is outwardly biased andcarries clamping surface 47 (e.g., in the manner shown in FIGS. 35G-35Iand FIGS. 35J-35L), second arm 65 may be omitted entirely, in which casethe distal end of clamping rod 15 preferably comprises only outwardlybiased first arm 60 (with clamping surface 47).

In still another form of the present invention, and looking now at FIGS.35M-35O, novel suture passer 5 may be constructed so that both first arm60 (carrying clamping surface 47) and second arm 65 are outwardlybiased, so that both first arm 60 (and clamping surface 47) and secondarm 65 extend out window 35 when clamping rod 15 is moved distally. Inthis form of the invention, funnel region 75 is formed between first arm60 and second arm 65. FIGS. 35P-35R show the novel suture passer ofFIGS. 35M-35O securing a suture S to the distal end of the suturepasser.

In another form of the present invention, and looking now at FIGS.36-40, window 35 may be eliminated, and clamping rod 15 may clamp sutureS against the distal end surface 80 of hollow tube 10.

Again, if desired, and looking now at FIGS. 40A and 40B, second arm 65of suture passer 5 may include a plurality of suture-engagingprojections 76 on its distal side. As noted above, suture-engagingprojections 76 allow the user to more aggressively engage (e.g., in acontact or frictional sense) suture S with second arm 65, whereby tofacilitate manipulation of suture S via engagement with second arm 65.Thus, for example, with the construction shown in FIGS. 40A and 40B, ifthe user needs to move the suture S about a surgical site, the user can“grip” the suture S with the suture-engaging projections 76 of secondarm 65 and “drag” the suture S into a desired position. In anotherexample, the suture-engaging projections 76 of second arm 65 can assistin dragging suture S against the distal end of hollow tube 10. Moreparticularly, as the clamping rod 15 is moved proximally in hollow tube10, the second arm 65 retracts into the lumen of hollow tube 10. As itdoes so, if the suture S is in contact with the suture-engagingprojections 76 of second arm 65, suture S will be drawn into engagementwith the distal end of hollow tube 10 and then clamped in place by firstarm 60.

Alternatively, if desired, second arm 65 of suture passer 5 may includea plurality of suture-engaging projections 76 on its proximal side(e.g., in a manner analogous to that shown in FIGS. 29C and 29D). Again,suture-engaging projections 76 allow the user to more aggressivelyengage (e.g., in a contact or frictional sense) suture S with second arm65, whereby to facilitate manipulation of suture S via engagement withsecond arm 65.

Again, it will be appreciated that, if desired, suture-engagingprojections 76 may also be provided on both the distal and proximalsides of second arm 65, and/or on one or both lateral sides of secondarm 65.

It will be appreciated that suture-engaging projections 76 essentiallyconstitute a suture engaging surface on second arm 65 so as to allowsecond arm 65 to engage and “drag” suture S about a surgical site. Tothis end, it will also be appreciated that the suture engagingsurface(s) on second arm 65 may be formed with a variety of geometries,e.g., barbs, fingers or other surface texturing which increases thefrictional aspects of second arm 65 at a desired location or locations.

Furthermore, if desired, and looking now at FIGS. 41-47, the distal endsurface 80 of hollow tube 10 can be disposed substantially perpendicularto the longitudinal axis of hollow tube 10, whereby to enhance clampingof suture S against distal end surface 80 of hollow tube 10. In thisconstruction, it may be desirable to provide a sharp point 85 to thedistal end of first arm 60, in order to facilitate passage of the suturepasser through tissue.

Handle

As noted above, suture passer 5 preferably comprises a handle 23, andhandle 23 preferably comprises an actuator 72 which actuates clampingrod 15 so as to clamp and/or release suture S. If desired, actuator 72may comprise a lock or detent which maintains the position of clampingrod 15 relative to hollow tube 10. For example, the lock or detent mayhold the clamping rod in a distal position and/or in a proximal position(e.g., while it is clamping suture S).

Actuator 72 may also comprise a spring to bias clamping rod 15proximally or distally. In one preferred form of the invention, thisspring biases the clamping rod in a proximal direction (for example, toclamp suture S between clamping surface 47 and inclined surface 45).

Novel “Spear” Suture Passer

Looking next at FIGS. 48-60, there is shown a novel suture passer 105also formed in accordance with the present invention. Suture passer 105will sometimes hereinafter be referred to as the “spear” suture passer.

More particularly, the spear suture passer 105 generally comprises anouter shaft tube 110, an inner guide tube 112 fixedly disposed withinthe interior of outer shaft tube 110, and a suture spear 116 slidablydisposed within the lumen of inner guide tube 112, as will hereinafterbe discussed in further detail.

More particularly, outer shaft tube 110 comprises a distal end 120preferably terminating in a sharp point 122, and a proximal end 125preferably terminating in a handle 123, with a lumen 130 extendingtherebetween. It will be appreciated that the pointed outer shaft tube110 essentially comprises a hollow needle adapted to pierce tissue.

Outer shaft tube 110 further comprises a window 135 which extendsradially into the outer shaft tube and communicates with lumen 130.Window 135 is sized so as to selectively receive a suture S therein, aswill hereinafter be discussed in further detail. Window 135 comprises apair of distal surfaces 140, a pair of proximal surfaces 145, and a pairof side surfaces 146. Preferably, distal surfaces 140 and proximalsurfaces 145 extend substantially perpendicular to the longitudinal axisof outer shaft tube 110 (FIG. 49), and side surfaces 146 preferablyextend substantially parallel to the longitudinal axis of outer shafttube 110 (FIG. 50). Distal surfaces 140 are preferably spaced fromproximal surfaces 145 by a distance which is somewhat larger than thediameter of suture S, so that window 135 provides an adequate seat forsuture S, as will hereinafter be discussed in further detail.

Outer shaft tube 110 is preferably formed out of a substantially rigidmaterial (e.g., stainless steel) so as to maintain rigidity when passingthrough tissue, particularly relatively tough fibrous tissue (e.g., thelabrum of the hip).

In one preferred form of the present invention, the distal end 120 ofouter shaft tube 110 is curved (see, for example, FIGS. 49, 58 and 59),however, it should also be appreciated that outer shaft tube 110 can beformed in other configurations well known in the art (e.g., straight,etc.).

Inner guide tube 112 comprises a distal end 150 and a proximal end 155,with a lumen 156 extending therebetween. Inner guide tube 112 is fixedlydisposed within outer shaft tube 110 so that the distal end 150 of innerguide tube 112 terminates proximal to window 135 in outer shaft tube110, with lumen 156 of inner guide tube 112 being substantially alignedwith the center of window 135. The distal end 150 of inner guide tube112 preferably terminates just proximal to window 135 of outer shafttube 110. See, for example, FIGS. 50, 52 and 53. As will hereinafter bediscussed, inner guide tube 112 acts as a guide and stiffening memberfor suture spear 116, which is selectively extendable out of the innerguide tube (and hence selectively extendable across window 135) andselectively withdrawable back into the inner guide tube (and henceselectively withdrawable out of window 135).

Suture spear 116 comprises a distal end 158 and a proximal end 159.Distal end 158 of suture spear 116 terminates in a point 161. It will beappreciated that suture spear 116 essentially comprises a needle which,as will hereinafter be discussed, is adapted to pierce suture. Suturespear 116 is slidably disposed within lumen 156 of inner guide tube 112,such that suture spear 116 can extend across window 135 (FIG. 52) or bewithdrawn from window 135 (FIG. 53). Preferably the proximal end 159 ofsuture spear 116 extends out of the proximal end 155 of inner guide tube112 and is connected to an actuator 172 (e.g., a thumb slide) which ismovably mounted to handle 123, such that movement of actuator 172relative to handle 123 will cause movement of suture spear 116 relativeto inner guide tube 112 (and hence relative to outer shaft tube 110).Specifically, movement of actuator 172 relative to handle 123 will causethe distal end of suture spear 116 to intrude across, or be withdrawnfrom, window 135 of outer shaft tube 110.

It should be appreciated that the distal end of inner guide tube 112 ispositioned within outer shaft tube 110 so that the inner guide tube (andhence the suture spear 116) is aligned with a suture S that is laid inwindow 135 so as to ensure that suture spear 116 can securely pierce thesuture S, as will hereinafter be discussed.

It will be appreciated that, on account of the foregoing construction, apiece of suture S may be clamped to the distal end of suture passer 105by (i) moving suture spear 116 proximally so that the distal end 158 ofsuture spear 116 is withdrawn from window 135 of outer shaft tube 110,in the manner shown in FIG. 54 (e.g., by moving actuator 172 proximallyrelative to handle 123); (ii) positioning the suture S in window 135(FIG. 55); and (iii) moving suture spear 116 distally (e.g., by movingactuator 172 distally relative to handle 123) so as to cause suturespear 116 to “spear” (e.g., penetrate) suture S, as shown in FIG. 56,whereby to secure suture S to suture passer 105.

It will also be appreciated that, on account of the foregoingconstruction, a speared piece of suture S (FIG. 56) may thereafter bereleased from suture passer 105 by (a) moving suture spear 116proximally (FIG. 57) so as to “unspear” suture S; and (b) causing sutureS to be withdrawn from window 135.

Using the Novel “Spear” Suture Passer to Pass Suture from the Near Sideof Tissue to the Far Side of Tissue

In one preferred form of the present invention, and looking now at FIGS.61-64, the novel suture passer 105 can be used to pass suture S from thenear side of tissue T to the far side of tissue T (i.e., in an“antegrade” manner).

More particularly, the preliminary loading of suture S into suturepasser 105 may be performed away from the surgical site (e.g., outsideof the patient) or it may be performed adjacent to the near side of thetissue T which is to be sutured (e.g., inside of the patient). Asdiscussed previously, suture S may be loaded into suture passer 105 byretracting suture spear 116 out of window 135 of outer shaft tube 110(FIG. 54), guiding suture S into window 135 (FIG. 55), and thenadvancing suture spear 116 distally through suture S (FIG. 56), wherebyto secure suture S to suture passer 105. See FIG. 61.

Suture passer 105 is then advanced distally so that window 135 passesthrough tissue T, whereby to carry suture S through the tissue (FIG.62). With suture S extending through tissue T, and looking now at FIG.63, suture spear 116 is retracted proximally so as to release suture Sfrom suture passer 105, and then suture passer 105 and/or suture S aremanipulated so that suture S is clear of window 135 (FIG. 63). Suturepasser 105 may then be withdrawn back through tissue T, leaving suture Sextending through tissue T, as shown in FIG. 64.

Using the Novel “Spear” Suture Passer to Draw Suture from the Far Sideof Tissue to the Near Side of Tissue

In another preferred form of the present invention, the spear suturepasser 105 can be used to draw suture S from the far side of tissue T tothe near side of tissue T (i.e., in a “retrograde” manner).

More particularly, in this form of the invention, the suture S is loadedinto suture passer 5 on the far side of the tissue T. This is done byfirst passing suture passer 105 through tissue T so that window 135resides on the far side of the tissue, and then moving suture spear 116proximally so that suture spear 116 is withdrawn from window 135 (if thesuture spear has not already been withdrawn from window 135). Suture S(disposed on the far side of tissue T) is then positioned into window135, and suture spear 116 is advanced distally so as to spear suture Sand secure the suture to suture passer 105. Outer shaft tube 110 is thenretracted proximally through tissue T, carrying suture S therethrough.If desired, suture S can then be released from suture passer 105 bymoving suture spear 116 distally.

Significantly, by alternating the aforementioned antegrade suturepassing procedure (FIGS. 61-64) with the aforementioned retrogradesuture passing procedure (discussed in the paragraph immediatelypreceding this paragraph), with the needle “plunges” being laterallyspaced from one another in the tissue, a mattress stitch may be placedin the tissue, as will be appreciated by one skilled in the art.

If desired, the spear suture passer 105 may also be used to pass sutureS around a side edge of the tissue T, rather than passing the suture Sthrough the tissue. By way of example but not limitation, if the outershaft tube 110 is passed around the side edge of the tissue (rather thanthrough the tissue), the suture passer could then be used to retrievethe suture on the far side of the tissue and draw it back around theside edge of the tissue so that the suture is brought to the near sideof the tissue.

As described above, the novel suture passer 105 has the ability to bothpass (advance) and retrieve (draw) the suture S through and/or aroundthe tissue in a continuous series of steps. This allows the surgeon tocomplete the desired suture passing without having to remove the suturepasser 105 from the portal through which the suture passer 105 is beingused. Significantly, this passing/retrieving process can be accomplishedwith a single instrument, rather than requiring one instrument forpassing and a separate instrument for retrieving. This offerssignificant advantages in convenience and in reducing surgery time.

If desired, the function of the inner guide tube 112 can be replaced bya rod 186 with a slot 187, as shown in FIG. 65. This rod 186 could alsohave other cross-sectional shapes (such as that of a ribbon, etc.) thatact to constrain the suture spear 116 to the desired position relativeto the window 135. This positioning scheme can also take the form ofmultiple wires filling the space where the suture spear is desired notto go.

The function of inner guide tube 112 can also be incorporated into theouter shaft tube 110. For example, the outer shaft tube 110 can have alumen 130 which is offset towards window 135, e.g., as shown in FIG. 66.

Additionally, suture spear 116 can occupy the entire internal diameterof lumen 130 of outer shaft tube 110. In this embodiment, and as shownin FIG. 67, the suture spear 116 is a rod with a sharpened feature 188(e.g., a point) located in the window 135. In this embodiment, the innerguide tube 112 is not required.

Additional Novel Suture Passer

Looking next at FIGS. 68-81, there is shown a novel suture passer 205formed in accordance with the present invention. Suture passer 205generally comprises a hollow tube 210 and a clamping rod 215 slidablydisposed within the lumen of hollow tube 210, as will hereinafter bediscussed in further detail.

More particularly, hollow tube 210 comprises a distal end 220 preferablyterminating in a sharp point 225, and a proximal end 230 preferablyterminating in a handle 235, with a lumen 240 extending therebetween. Itwill be appreciated that the pointed hollow tube 210 essentiallycomprises a hollow needle adapted to pierce tissue.

Hollow tube 210 further comprises a cutaway 245 disposed just proximalto sharp point 225 and which communicates with lumen 240. Cutaway 245preferably comprises a pair of longitudinally-extending edges 250 whichterminate at their proximal ends at a circumferentially-extending edge255. Preferably circumferentially-extending edge 255 is recessed at 260so as to form seats for a suture grasped by suture passer 205, as willhereinafter be discussed. Alternatively, recess 260 can be omitted fromcircumferentially-extending edge 255 (e.g., circumferentially-extendingedge 255 can be formed with a substantially “flat” profile).

Hollow tube 210 is preferably formed out of a substantially rigidmaterial (e.g., stainless steel) so as to maintain rigidity when passingthrough tissue, particularly relatively tough fibrous tissue (e.g., thelabrum of the hip, the capsule of the hip joint, etc.).

In one preferred form of the present invention, the distal end 220 ofhollow tube 210 is curved, however, it should be appreciated that hollowtube 210 can be formed in other configurations well known in the art(e.g., straight, compound curves, etc.).

Clamping rod 215 comprises a distal end 265 and a proximal end 270.Distal end 265 of clamping rod 215 is bifurcated so as to form a firstarm 275 and a second arm 280. The distal ends of first arm 275 andsecond arm 280 are biased laterally so that first arm 275 and second arm280 will extend both distally and laterally when the distal ends offirst arm 275 and second arm 280 are advanced distally out of the distalend of hollow tube 210, as will hereinafter be discussed in furtherdetail. Preferably first arm 275 and second arm 280 have differentdegrees of lateral bias so that they will together define a funnelregion therebetween when the distal ends of first arm 275 and second arm280 are advanced distally out of the distal end of hollow tube 210, aswill hereinafter be discussed in further detail.

More particularly, first arm 275 comprises a clamping surface 285, withclamping surface 285 extending radially from the longitudinal axis ofclamping rod 215. Clamping surface 285 may take the form of a hook, asshown in the construction illustrated in FIGS. 68-81. This hook helpstrap the suture S between clamping surface 285 of clamping rod 215 andthe aforementioned recesses 260 of circumferentially-extending edge 255of hollow tube 210, in the manner shown in FIGS. 77 and 78.

First arm 275 is outwardly biased so that when first arm 275 advancesalong cutaway 245, first arm 275 passes radially outwardly through thecutaway so as to project at an angle of approximately 60 degreesrelative to the adjacent longitudinal axis of hollow tube 210, wherebyto create one half of a funnel region 290 established between first arm275 and second arm 280 when first arm 275 and second arm 280 extend outof cutaway 245 (FIG. 73). To this end, first arm 275 is preferablyformed out of a material consistent with this spring bias (e.g., asuperelastic material such as Nitinol, etc.). In one preferred form ofthe invention, the entire clamping rod 215 is formed out of asuperelastic material such as Nitinol.

Second arm 280 extends parallel to first arm 275 when clamping rod 215is disposed within lumen 240 of hollow tube 210, with second arm 280terminating proximally of first arm 275, proximal of clamping surface285 (FIG. 70). Second arm 280 comprises a recess 295 at its distal tip.Recess 295 forms a seat for suture S at the distal tip of second arm280, such that when a suture S is seated in cutaway 245 and second arm280 thereafter extends out of cutaway 245, recess 295 in second arm 280will engage suture S and carry suture S away from cutaway 245, wherebyto help separate suture S from suture passer 205. In one preferred formof the invention, recess 295 comprises a distal finger 300, a proximalfinger 305 and a groove 310 formed therebetween. If desired, distalfinger 300 and proximal finger 305 may have substantially the samelength and/or width.

Second arm 280 is outwardly biased so that when second arm 280 advancesalong cutaway 245, second arm 280 passes radially outwardly through thecutaway 245 so as to project at an angle of approximately 90 degreesrelative to the adjacent longitudinal axis of hollow tube 210, wherebyto create the aforementioned funnel region 290 between first arm 275 andsecond arm 280 when first arm 275 and second arm 280 extend out ofcutaway 245. To this end, second arm 280 is preferably formed out of amaterial consistent with this spring bias (e.g., a superelastic materialsuch as Nitinol, etc.). As noted above, in one preferred form of theinvention, the entire clamping rod 215 is formed out of a superelasticmaterial such as Nitinol.

The gap between first arm 275 and second arm 280 (see gap G in FIG. 76)is carefully sized, i.e., it is larger than the diameter of a suture soas to prevent a suture from being inadvertently lodged between first arm275 and second arm 280, which could effectively jam the components, butnot so large that the transfer of suture S from first arm 275 to secondarm 280 is undermined. In one preferred form of the invention, the gapbetween first arm 275 and second arm 280 is approximately 1-3 times thediameter of the suture, and preferably about 1.5 times the diameter ofthe suture.

In one preferred form of the present invention, second arm 280 maycomprise a compound curve 315 (FIG. 73) so as to facilitate properdisposition of second arm 280 when it is projected distally andlaterally out of cutaway 245.

If desired, the degree of the outward bias of first arm 275 and secondarm 280 can be varied from the angles described above, e.g., first arm275 can extend at an angle of approximately 45 degrees relative to theadjacent longitudinal axis of hollow tube 210 when first arm 275advances out of the distal end of hollow tube 210, and second arm 280can extend at an angle of approximately 135 degrees relative to theadjacent longitudinal axis of hollow tube 210 when second arm 280advances out of the distal end of hollow tube 210. In one form of theinvention, first arm 275 can extend at an angle of 0-90 degrees relativeto the adjacent longitudinal axis of hollow tube 210, and second arm 280can extend at an angle of 20-160 degrees relative to the adjacentlongitudinal axis of hollow tube 210 (but in any case at an angle whichis less than the angle of the first arm so that the two arms do notcross over one another). Still other appropriate constructions will beapparent to those skilled in the art in view of the present disclosure.

The proximal end 270 of clamping rod 215 extends through lumen 240 ofhollow tube 210 and is connected to an actuator 320 which is movablymounted to handle 235, such that movement of actuator 320 relative tohandle 235 causes movement of clamping rod 215 relative to hollow tube210.

It will be appreciated that, on account of the foregoing construction, apiece of suture S may be clamped to the distal end of suture passer 205by (i) moving clamping rod 215 to the position shown in FIGS. 72 and 73(e.g., by moving actuator 320 distally relative to handle 235) so thatfirst arm 275 and second arm 285 extend distally and laterally out ofcutaway 245 and create the aforementioned funnel region 290; (ii)positioning the suture S in funnel region 290 (FIG. 74), preferablymoving suture passer 205 and/or suture S as appropriate so as to settlethe suture S deep within funnel region 290 (i.e., close to or againstthe pair of longitudinally-extending edges 250 and/or thecircumferentially-extending edge 255, or hooking suture S with theclamping surface 285 of first arm 275; and (iii) moving clamping rod 215proximally (e.g., by moving actuator 320 proximally relative to handle235) so as to cause clamping surface 285 of first arm 275 to engagesuture S (FIGS. 75 and 76) and retract suture S proximally, whereby toclamp suture S against recesses 260 of circumferentially-extending edge255 of hollow tube 210, as shown in FIGS. 77 and 78. In this respect itwill be appreciated that the creation of the funnel region 290(established between the extended first arm 275 and the extended secondarm 280) at the mouth of cutaway 245 facilitates guidance of suture Sinto clamping position, as shown in FIGS. 74-78.

It will also be appreciated that, on account of the foregoingconstruction, a clamped piece of suture S may thereafter be releasedfrom suture passer 205 by (a) moving clamping rod 215 distally (FIGS.77-81) so as to space clamping surface 285 of first arm 275 away fromrecesses 260 of circumferentially-extending edge 255 of hollow tube 210,whereby to release suture S from its clamped condition, and with recess295 of second arm 280 engaging suture S and driving it distally andlaterally, so that suture S moves clear of cutaway 245 (FIGS. 79-81);and (b) causing suture S to be withdrawn from the suture passer, eitherby moving suture S relative to suture passer 205, or by moving suturepasser 205 relative to suture S, or by moving both suture S and suturepasser 205 relative to one another.

It should be appreciated that, in one preferred form of the invention,when clamping rod 215 is moved proximally, both first arm 275 and secondarm 280 are disposed within lumen 230 of hollow tube 210, so that thedistal end of suture passer 205 presents a smooth outer surface, wherebyto facilitate passage of the distal end of suture passer 205 throughtissue.

Using the Novel Suture Passer to Pass Suture from the Near Side ofTissue to the Far Side of Tissue

In one preferred form of the present invention, the novel suture passer205 can be used to pass suture S from the near side of tissue to the farside of tissue (i.e., in an “antegrade” manner).

More particularly, the preliminary loading of suture S into suturepasser 205 may be performed away from the surgical site (e.g., outsideof the patient) or it may be performed adjacent to the near side of thetissue which is to be sutured (e.g., inside of the patient). This isachieved by advancing clamping rod 215 to its distalmost position sothat first arm 275 and second arm 280 advance out of cutaway 245,whereby to project the distal ends of the first and second arms out ofthe axis of hollow tube 210 and create the aforementioned funnel region290. Suture S is then guided into cutaway 245 using this funnel effect,either by moving suture S relative to suture passer 205, or by movingsuture passer 205 relative to suture S, or by moving both suture S andsuture passer 205 relative to one another. If desired, the suture S maybe tensioned so as to help draw it into cutaway 245. Or suture S may behooked with clamping surface 285 of first arm 275. Clamping rod 215 isthen retracted proximally so that clamping surface 285 of first arm 275clamps suture S between clamping surface 285 of first arm 275 andrecesses 260 of circumferentially-extending edge 255 of hollow tube 210.

Suture passer 205 is then advanced distally so that cutaway 245 passesthrough tissue, whereby to carry suture S through the tissue. Withsuture S extending through the tissue, clamping rod 215 is advanceddistally so that first arm 275 and second arm 280 extend out of cutaway245, thereby spacing clamping surface 285 fromcircumferentially-extending edge 255 of hollow tube 210, whereby torelease suture S from suture passer 205 and with second arm 280 drivingsuture S before it as second arm 280 advances distally and proximallyout of cutaway 245. See FIG. 79. Preferably, second arm 280 can flexproximally slightly at the end of the distal stroke, whereby to allowsuture S to “slip off” the distal end of second arm 280. (see FIG. 81).In this respect it will be appreciated that second arm 280 is flexible,but also has column strength, so that second arm 280 can drive thesuture S distally relative to hollow tube 210, but then, as the portionof second arm 280 projecting out of hollow tube 210 gets longer andlonger, the second arm 280 eventually “flops over” under the drag of thesuture S which is being pushed by second arm 280, whereby to causesuture S to fall free of second arm 280. Suture passer 205 and/or sutureS are then manipulated so that suture S is clear of suture passer 205.Clamping rod 215 is then moved proximally so as to retract first arm 275and second arm 280 back into hollow tube 210. Suture passer 205 may thenbe withdrawn back through the tissue, leaving suture S extending throughthe tissue.

Significantly, by providing second arm 280 of clamping rod 215 with arecess 295, the suture being driven forward by second arm 280 ofclamping rod 215 can be “controlled” longer during the distal stroke,i.e., the suture can be retained for a longer period of time on thedistally-moving second arm 280 of clamping rod 215. As a result, it ispossible to advance longer lengths of suture through the tissue withoutdriving the needle further through the tissue. This can be highlyadvantageous where longer lengths of suture may be required on the farside of the tissue, e.g., when suturing closed the capsule of the hipjoint at the conclusion of an arthroscopic procedure but where theneedle cannot be advanced further (e.g., if bone obstructs furtherpassage of the needle, such as in a hip joint). At the same time, byforming second arm 280 out of a flexible, outwardly biased material, asthe second arm 280 extends further and further out of hollow tube 210,the drag on suture S will eventually cause second arm 280 to “flopover”, whereby to release the suture S from second arm 280.

Using the Novel Suture Passer to Draw Suture from the Far Side of Tissueto the Near Side of Tissue

In another preferred form of the present invention, the novel suturepasser 205 can be used to draw suture S from the far side of tissue tothe near side of tissue (i.e., in a “retrograde” manner).

More particularly, in this form of the invention, the suture S is loadedinto suture passer 205 on the far side of the tissue. This is done byfirst passing suture passer 205 through the tissue so that cutaway 245resides on the far side of the tissue, and then moving clamping rod 215distally so that first arm 275 and second arm 280 extend distally andproximally out of cutaway 245, whereby to create the aforementionedfunnel region 290. This funnel effect is then used to guide a freesuture (disposed on the far side of the tissue) into cutaway 245, eitherby moving suture S relative to suture passer 205, or by moving suturepasser 205 relative to suture S, or by moving both suture S and suturepasser 205 relative to one another. If desired, the suture S may betensioned so as to help draw it into cutaway 245. Or suture S may behooked with clamping surface 285 of first arm 275.

Next, clamping rod 215 is retracted proximally so as to releasablysecure suture S between clamping surface 285 of first arm 275 andrecesses 260 of circumferentially-extending edge 255 of hollow tube 210.Suture passer 205 is then retracted proximally through the tissue,carrying suture S therethrough. Suture S can then be released fromsuture passer 205 by moving clamping rod 215 distally, whereby to causesecond arm 280 to drive suture S out of cutaway 245 and clear of suturepasser 205.

Forming First Arm 275 without an Outward Bias

If desired, first arm 275 can be formed without an outward bias, so thatonly second arm 280 has an outward bias. In this form of the invention,the funnel region 290 is still formed between the distal ends of firstarm 275 and second arm 280, however, the funnel region 290 will extendat a different angle relative to the longitudinal axis of hollow tube210 than where both first arm 275 and second arm 280 are outwardlybiased.

Forming Second Arm 280 with a Modified Construction

If desired, and looking now at FIGS. 82-84, second arm 280 may be formedwithout the aforementioned compound curve 315.

Furthermore, if desired, recess 295 at the distal tip of second arm 280may be formed with a different geometry, e.g., so as to facilitateseparation of suture S from second arm 280 at the end of the secondarm's distal stroke. By way of example but not limitation, recess 295may comprise a longer distal finger 300 and a shorter proximal finger305, with the groove 310 being formed therebetween. As a result of thisconstruction, when a suture S is seated in cutaway 245 and second arm280 thereafter extends out of cutaway 245, recess 295 in second arm 280will engage suture S and carry suture S away from cutaway 245, and theshorter proximal finger 305 will thereafter facilitate separation ofsuture S from suture passer 205. In effect, and as best seen in FIG. 84,as second arm 280 moves further and further out of hollow tube 210, thesecond arm 280 becomes progressively less supported by hollow tube 210which, at the end of the second arm's distal stroke and in combinationwith the shorter proximal finger 305, allows the suture S to fall awayfrom second arm 280 in the proximal direction. In this respect it willalso be appreciated that where suture S extends through tissue proximalto second arm 280, friction between suture S and this tissue duringdistal movement of second arm 280 imposes a proximally-directed force onsuture S, which (i) helps cause second arm 280 to bend proximally at theend of its distal stroke, thereby directing groove 310 more proximally,and (ii) helps suture S to pull off second arm 280. If desired, secondarm 280 can be formed with proximal finger 305 omitted, so that secondarm 280 comprises only the distal finger 300.

Additionally, if desired, and looking now at FIGS. 85 and 86, recess 295at the distal end of second arm 280 may be replaced by a relativelyshort spike 325. In this form of the invention, when a suture S isseated in cutaway 245 and second arm 280 thereafter extends out ofcutaway 245, spike 325 at the distal end of second arm 280 piercinglyengages suture S and help hold suture S on the distal end of second arm280 as second arm 280 extends out of cutaway 245, whereafter therelatively short spike 325 allows suture S to separate from suturepasser 205. More particularly, it will be appreciated that as second arm280 moves further and further out of hollow tube 210, the second arm 280becomes progressively less supported by hollow tube 210 which, incombination with the relatively short length of spike 325, allows thesuture S to fall away from second arm 280 in the proximal direction. Inthis respect it will also be appreciated that where suture S extendsthrough tissue proximal to second arm 280, friction between suture S andthis tissue during distal movement of second arm 280 imposes aproximally-directed force on suture S, which (i) helps cause second arm280 to bend proximally at the end of its distal stroke, therebydirecting spike 325 more proximally, and (ii) helps suture S to pull offsecond arm 280.

Additional Aspects of the Invention

Significantly, by alternating the aforementioned antegrade suturepassing procedure with the aforementioned retrograde suture passingprocedure, with the needle “plunges” being laterally spaced from oneanother in the tissue, a mattress stitch may be placed in the tissue.

If desired, the novel suture passer 205 may also be used to pass sutureS around a side edge of the tissue, rather than passing the suture Sthrough the tissue. By way of example but not limitation, if the hollowtube 210 is passed around the side edge of the tissue (rather thanthrough it), the suture passer could then be used to retrieve the sutureon the far side of the tissue and draw it back around the side edge ofthe tissue so that the suture is brought to the near side of the tissue.

As described above, the novel suture passer 205 has the ability to bothpass (advance) and retrieve (draw) the suture S through and/or aroundthe tissue in a continuous series of steps. This allows the surgeon tocomplete the desired suture passing without having to remove the suturepasser 205 from the portal through which the suture passer 205 is beingused. Significantly, this passing/retrieving process can be accomplishedwith a single instrument, rather than requiring one instrument forpassing and a separate instrument for retrieving. This offerssignificant advantages in convenience and in reducing surgery time.

Modifications

It should also be understood that many additional changes in thedetails, materials, steps and arrangements of parts, which have beenherein described and illustrated in order to explain the nature of thepresent invention, may be made by those skilled in the art while stillremaining within the principles and scope of the invention.

What is claimed is:
 1. A method for passing a suture through tissuecomprising: positioning a suture passer in a surgical cavity, whereinthe suture passer comprises a hollow tube, a suture retainer received inthe hollow tube and configured to extend from and retract into a distalend of the hollow tube, a distal portion of the suture retainercomprising a first arm and a second end arm, the first arm extendingdistally of the second arm, a distal portion of the first armcomprising: a first surface portion that faces distally and forms ablunt end of the distal portion of the first arm, a second surfaceportion that faces distally and extends proximally from the firstsurface portion at an angle relative to the first surface portion, and arecess formed at least partially by a proximally extending portion thatis proximal of the second surface portion and is configured to extendalong a suture when the suture is located in the recess; retaining asuture with the suture passer by locating the suture in the recess ofthe distal portion of the first arm and preventing the suture frommoving laterally with respect to the tube of the suture passer via theproximally extending portion; and passing the suture passer with theretained suture through the tissue.
 2. The method of claim 1,comprising, prior to retaining the suture, extending the suture retainerfrom the tube and locating the suture between the first arm and thesecond arm.
 3. The method of claim 2, comprising retracting the sutureretainer into the tube while pulling the suture proximally.
 4. Themethod of claim 2, comprising extending the second arm laterallyoutwardly from the tube.
 5. The method of claim 1, comprising retainingthe suture between a wall of the recess and a distal facing portion ofthe hollow tube.
 6. The method of claim 1, wherein the tissue is alabrum.
 7. The method of claim 1, wherein the tissue is a joint capsule.8. The method of claim 1, wherein the tissue is located in the hip.
 9. Amethod for passing a suture through tissue comprising: positioning asuture passer in a surgical cavity, wherein the suture passer comprisesa tube defined by a wall and a suture retainer received in the tube andconfigured to extend at least partially out of the tube, wherein thetube has a distal portion that comprises a distal end of the tube and acutaway in a side of the wall, and a proximal portion of the cutawaycomprises a retaining surface, wherein the distal portion of the tubecomprises a taper that forms a pointed distal end for piercing thetissue and the distal end of the suture retainer is proximal of aproximal end of the taper; retaining a suture between the retainingsurface of the cutaway and a proximally facing portion of a distalportion of the suture retainer such that the suture is retained againstthe retaining surface of the cutaway, wherein a distal end of the sutureretainer is distal to the retaining surface of the cutaway and proximalto the distal end of the tube; and passing the suture passer with theretained suture through the tissue.
 10. The method of claim 9, whereinretaining the suture comprises extending the suture retainer from thetube and retracting the suture retainer into the tube while pulling thesuture proximally.
 11. The method of claim 9, wherein passing the suturepasser through the tissue comprises piercing tissue with the suturepasser.
 12. The method of claim 9, wherein the tissue is a labrum. 13.The method of claim 9, wherein the tissue is a joint capsule.
 14. Themethod of claim 9, wherein the tissue is located in the hip.